Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Fiber for Endometriosis

This study is a neither you nor the study doctors know who gets the real treatment, randomly assigned, compared with a dummy treatment study that evaluates the whether it is safe and how hard side effects are to live with of a fiber-based dietary supplement and the mechanistic and structure-function effects of that supplement on the gut and vaginal microbiome, gastrointestinal well-being, and quality-of-life parameters in 140 women with endometriosis and co-existing gastrointestinal symptoms over 12 weeks. The primary objective is to measure the whether it is safe and how hard side effects are to live with of the supplement, measured by the incidence and severity of gastrointestinal side effects (AEs) and discontinuations.

Official registry: https://clinicaltrials.gov/study/NCT07875062 · LOAM Science · enrollment listed as 140

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Fiber, or Placebo. The registry lists allocation as randomized. This study is a neither you nor the study doctors know who gets the real treatment, randomly assigned, compared with a dummy treatment study that evaluates the whether it is safe and how hard side effects are to live with of a fiber-based dietary supplement and the mechanistic and structure-function effects of that supplement on the gut and vaginal microbiome, gastrointestinal well-being, and quality-of-life parameters in 140 women with endometriosis and co-existing gastrointestinal symptoms over 12 weeks.

They plan to enroll about 140 people at San Francisco. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Mechanistic Effects of a Multi-Fiber Prebiotic Dietary Supplement (LOAM) on the Gut and Vaginal Microbiome, Gastrointestinal Well-Being, and Quality-of-Life Parameters in Women With Endometriosis and Co-Existing Gastrointestinal Symptoms

Interventions: Fiber, Placebo

Primary outcome (registry wording): Incidence and severity of GI adverse events (AEs) and discontinuations.

Who it is for (from inclusion criteria)

  • Ages 18 Years to 45 Years
  • Women only
  • Confirmed diagnosis of endometriosis (by imaging, laparoscopy, or physician clinical assessment)
  • Enriched gastrointestinal phenotype: self-reported gastrointestinal symptoms on at least 3 days per week for the preceding 3 months, including at least one of bloating, constipation, or abdominal discomfort
  • Predominantly Bristol Stool Scale Type 1-3 (constipation-predominant), or self-reported bloating as a dominant symptom
  • Stable hormonal status: either no hormonal therapy, or stable hormonal therapy (combined oral contraceptive, progestin, or GnRH analogue) for at least 3 months with no planned change during the study
  • Estimated habitual dietary fiber intake below 25 g/day based
  • Willingness to share menstrual cycle data
  • Willing to maintain stable diet, physical activity, and medication regimens throughout the study

Public study contact (from the registry)

Bryce Jarman, PhD

323-325-1327

bryce@loamscience.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07875062 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07875062?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07875062?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary